Life threatening arrhytmias such as Ventricular Tachycardia or Fibrillation and/or severe bradyarrhytmias are the main ethiology of out-of-hospital cardia arrest. The number one mortality ethiology in western world is cardiac disease. In particular, Myocardial infarction which is the medical term for a “heart attack,” is a type of cardiac arrest. When a heart attack occurs, with a subsequent life threatening arrhytmias that alter the pumping action of the heart, the heart is disrupted such that it does not pump sufficient blood. Broadly speaking, the heart may either stop pumping or it may pump irregularly. In either situation, a trained medical professional can use a one-lead rhythm strip electrocardiograph to evaluate a patient's heart.
At its most basic, electrocardiography is a graphical interpretation of electrical activity of the heart over a period of time, as detected by electrodes attached to the surface of the skin and collected by a device external to the patient's body. An electrocardiogram (ECG or EKG are two abbreviations of the term “electrocardiogram) measures the electrical impulses generated by the polarization and de-polarization of cardiac tissue of the heart. The EKG translates these electrical impulses into a waveform. The waveform is used to determine the rate and regularity of the subject's heartbeats. Although to establish a diagnoses of a heart attack a 12-lead ECG is currently required, one lead is generally sufficient to detect significant arrhytmias that may require a treatment with a defibrillator or a pacemaker in an emergent setting. For example, the characteristic waveform of one beat of a normal heart is illustrated at FIG. 1A. FIG. 1B illustrates an EKG of a normal heart. FIG. 1B illustrates a cardiac cycle representing a P wave, a QRS complex, a T wave and a baseline b that follows until another P wave appears. FIG. 2A illustrates a characteristic waveform of a severe bradyarrhytmia sb that requires stimulation, also known as pacing, by a pacemaker to regulate the heartbeat. FIG. 2B illustrates a characteristic waveform of a severe tachycardia st. FIGS. 3A, illustrating ventriular flutter vf, and 3B, illustrating ventricular fibrilation vf′, illustrate characteristic waveforms of a patient that has suffered a heart attack where the electrical activity of the patient's heart is irregular and potentially chaotic. In this situation, the patient's heart is beating, but the chambers are firing chaotically and insufficient blood is being pumped by the patient's heart. In this situation, a defibrillator is used to depolarize the heart muscle and terminate the dysrhythmia and allow the patient's body to reestablish a normal sinus rhythm.
At the present time, EKG data can be monitored and transmitted from the patient to a doctor's office or a health service center. For example, U.S. Pat. No. 8,509,882 discloses a personal monitoring device with a sensor assembly configured to sense physiological signals upon contact with the patient's skin. The sensor assembly produces electrical signals representing the sensed physiological signals. A converter assembly, integrated with and electrically contented to the sensor assembly, converts the electrical signals generated by the sensor assembly to a frequency modulated physiological audio signal having a carrier frequency in the range of from about 6 kHz to about 20 kHz.
Additional examples of patient monitoring are disclosed in U.S. Pat. No. 5,735,285 which discloses use of a hand-held device that converts a patient's EKG, also referred to as an ECG, into a frequency modulated audio signal that may then be analyzed by audio inputting via a telephone system to a selected hand-held computer device or to a designated doctor's office.
U.S. Patent Application Publication No. 2010/0113950 discloses an electronic device having a heart sensor including several leads for detecting a user's cardiac signals. The leads are coupled to interior surfaces of the electronic device housing to hide the sensor from view. Using detected signals, the electronic device can then identify and authenticate the user.
While all of the above are useful in diagnosing conditions of the patient's heart, they do not address the problem of treatment before hospital admission. Diagnosis can also be particularly problematic because the patient may be unstable or unconscious. It is known that early defibrillation/pacing and CPR is critical in out-of-hospital cardiac arrest. Typically, earlier treatment results in significantly higher long-term rates of survival and less acute damage to the patient's heart, and potentially, the patient's brain. Thus, it would be desirable to permit an emergent bystander to diagnose and provide treatment with the option of a medical professional to oversight the patient's management remotely. The present disclosure permits a bystander to diagnose and treat onsite and a medical professional to both remotely diagnose and remotely treat the patient. Phrased differently, an emergent bystander without a medical degree or training as a first-responder, also referred to as paramedic, could employ the presently disclosed device to diagnose and treat the patient with the option of a medical professional to oversight the patient's management remotely. It is believed that this presently disclosed device will be particularly useful for a family member to diagnose and treat the family member's cardiac situation when the family member is remote from a hospital or doctor's office.